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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Etanercept 50mg, subcutaneous, once weekly

The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid arthritis with regard to signs and symptoms and to determine what dose is favourable over a 6-month treatment period. Patients will receive background treatment with either Methotrexate or Sulphasalazine

A 6-month randomised, double-blind, open arm comparator, phase IIb, with AZD9056, in patients with Rheumatoid Arthritis (RA)

Research Site

A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine

The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 6 months’ treatment

Age Continuous

Gender, Male/Female

Hybrid ACR, ACRn, individual ACR components, Erythrocyte sedimentation rate, Short-form-36, Rheumatoid Arthritis Quality of Life, Patient Assessment of Fatigue and DEXA X-ray scanning did not provide extra information so are not presented

American College of Rheumatology 20 response (ACR20) at 6 months

The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 6 months’ treatment.

American College of Rheumatology 50 response (ACR50) at 6 months

The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 6 months’ treatment

American College of Rheumatology 70 response (ACR70) at 6 months

Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of disease activity; and ESR) after 6 months’ treatment.  A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. (The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms).

Disease Activity Score (based on 28 joint count) (DAS28) at 6 months.

Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months’ treatment, calculated as score at 6 months minus score at baseline.  A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. (The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability).

Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 months.

Overall Study

Male/female participants with active rheumatoid arthritis (and on background methotrexate or sulphasalazine) were randomly assigned to receive AZD9056 at 50, 100, 200 or 400 mg once daily, placebo or etanercept.  It was planned to randomise approximately 360 participants, 60 to the open-label etanercept arm and 300 to the AZD9056 or placebo arms

Arms	Assigned Interventions
Active Comparator: 1 Etanercept 50mg, subcutaneous, once weekly	-
Experimental: 2 50mg oral, once daily	-
Experimental: 3 100 mg oral, once daily	-
Experimental: 4 200 mg oral, once daily	-
Experimental: 5 400mg once, daily	-
Placebo Comparator: 6 oral, once daily	-

A 6-month randomised, double-blind, open arm comparator, phase IIb, with AZD9056, in patients with Rheumatoid Arthritis (RA)

Official Title

Medical condition

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Study design

Verification:

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Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=278&filename=CSR-D1520C00001.pdf

CSR-D1520C00001.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator